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In a previous post, my colleague Fran DeGrazio discussed lifecycle planning and the use of a single material for packaging components from development through commercialization. There has been a great deal of innovation around drug container materials. Although glass has been the traditional material of choice for drug containment, it has significant limitations including breakage, glass particulate, visual quality and functional performance.
Glass syringe systems require siliconization to enable mechanical performance when used in a delivery system, and this material can interact with certain drug products, causing aggregation.
Recent developments around the use of polymeric materials for drug containment have allowed delivery system companies to work closely with drug manufacturers to develop novel systems designed specifically to meet patient needs. The design and manufacturing flexibility of a polymeric drug container, combined with the ability to create patient-friendly devices designed with human factors engineering, enables the design of more innovative overall delivery systems that may aid in patient compliance through ease of use and enhanced technology. Cyclic olefin polymers such as the Daikyo Crystal Zenith® polymer provide a transparent, break-resistant alternative to glass.
West markets SmartDose® and ConfiDose® as integrated systems with drug filling and final assembly performed by the pharmaceutical customer.
At West, we actively foster an inclusive and collaborative culture for our team members where different views and perspectives are welcomed and valued. We are convinced that this approach brings forth innovation, learning and growth for our team members on a global basis.
In 2018, CNDA (National Drug Administration of China) issued Technical Guidance of Drug Compatibility with Rubber Elastomer Closures. This clearly demonstrates a focus on administrative guidelines for the safe and effective use of rubber components, which along with plastic and glass, are the most widely used materials in the packaging of parenteral drug products.
Ophthalmic drug products (ODPs) present a special challenge for the measurement of extractables and leachables (E&L) due to the presence of multiple leachables sources. ODPs typically are packaged in labelled, semipermeable polymer (e.g., low density polyethylene) containers (i.e., primary container) and stored in cardboard containers (i.e., secondary container) along with instructions for use. The polymer, label, cardboard and paper are all possible sources of leachables.
West is honored to celebrate Black History Month with educational opportunities and ongoing discussion as One West Team. We strive to build and maintain a culture where we value each other as fellow human beings; our policies and practices are just, inclusive and equitable; and all feel a sense of belonging.
Pharmaceutical manufacturers are faced with numerous challenges to produce, package, and ship products successfully to the patient or care giver. Common concerns for all pharmaceutical manufactures include meeting targeted timelines, guarding against drug shortages, increasing speed to market, and generating revenue. Maximizing operating speeds and minimizing operating down time are critical factors for all stakeholders.
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